The present invention relates generally to rapid, non-destructive, selective infrared spectrometry analysis of organic coatings on molded articles. More particularly, the invention relates to such analysis of sub-micron coatings and mold lubricant residues on disposable thermoplastic medical articles such as syringes, auto-injector cartridges, and vials used to contain, store, or deliver pharmaceutical agents, body fluids, diagnostic reagents, and other fluid materials.
The present invention also relates to a pharmaceutical package or other container and to a method for coating or layering an inner or interior surface of a pharmaceutical package or other container. The present invention also relates more generally to medical devices, including devices other than packages or containers, for example catheters.
The present disclosure also relates to improved methods for processing pharmaceutical packages or other containers, for example multiple identical pharmaceutical packages or other containers used for pharmaceutical preparation storage and delivery, venipuncture and other medical sample collection, and other purposes. Such pharmaceutical packages or other containers are used in large numbers for these purposes, and must be relatively economical to manufacture and yet highly reliable in storage and use.
One important consideration in manufacturing pre-filled syringes and cartridges or other containers (such as vials) for storing or other contact with fluids, for example, is that the contents of the pharmaceutical package or other container desirably will have a substantial shelf life. During this shelf life, it is important to isolate the material filling the pharmaceutical package or other container from the container wall containing it, or from a barrier coating or layer or other functional coatings or layers applied to the pharmaceutical package or other container wall to avoid leaching material from the pharmaceutical package or other container wall, barrier coating or layer, or other functional coatings or layers into the prefilled contents or vice versa.
Commonly, after it is filled, a prefilled syringe or cartridge is capped at the distal end, as with a needle shield or other type of cap, and is closed at the proximal end by its drawn plunger tip or piston. The prefilled syringe or cartridge can be wrapped in a sterile package before use. To use the prefilled syringe or cartridge, the packaging and needle shield or other type of cap are removed, optionally a hypodermic needle or other type of dispenser is attached (if not already present), the delivery conduit or syringe is moved to a use position (such as by inserting the hypodermic needle into a patient's blood container or into apparatus to be rinsed with the contents of the syringe), and the plunger tip or piston is advanced in the barrel to inject the contents of the barrel. If a cartridge is being used, it is also placed into a mechanism that mechanically advances the piston to make an injection, for example using an injection spring.
Another important consideration is reliability of manufacture of pre-filled syringes, cartridges, vials, or other containers for storing or otherwise contacting injectable pharmaceutical materials and other fluids. Since many of these containers are inexpensive and used in large quantities, for certain applications it will be useful to reliably obtain the necessary shelf life without increasing the manufacturing cost to a prohibitive level. To address this need, it will be useful to develop rapid, inexpensive inspection methods that can be used to non-destructively inspect each container manufactured for any defects that may impact on its performance. For example, the coatings applied to thermoplastic containers to improve their barrier properties and prevent interaction of fluid contents with the container are desirably inspected before filling the containers with a costly medication or diagnostic material.
Traditional infrared (IR) spectrometry methods for detection of submicron coatings are IR reflectance methods, such as Fourier Transform Infrared-Attenuated Total Reflectance (FTIR-ATR). These methods require contact of the coating with an ATR crystal having a flat surface, typically made of sapphire. As a consequence, non-flat coated substrates (e.g. vials, syringe barrels) must be cut into small sections and compressed onto this sapphire stage for measurement, which is a destructive test. Also, contact of the coating surface to the spectrometer sapphire window is required, which can affect the coating.
These methods will tend to damage the coating, and thus are undesirable for inspection of the actual containers to be filled with a pharmaceutical or diagnostic material and distributed for medical use.